What differentiates studies that enroll well from those that do not?
We are completing a large survey involving more than 150 investigators and study coordinators globally looking at just this question. In this survey, we evaluated the comparative frequency of more than 100 factors among studies that did and did not enroll well. We will be publishing these data during the next few months. In the meantime, here are a few interesting findings.
Even when a study enrolled well, 39% of site staff noted payments to the site were delayed. When a study enrolled less well, 54% of site staff noted payments were delayed.
An even bigger discrepancy is noted for inadequate payment due to screen failure/randomization ratios. When a study enrolled well, an issue was noted by 19% of site staff. In contrast, 46% noted screen failure/randomization to be an issue for studies that recruited poorly.
These findings are consistent with the commissioned projects we’ve conducted for clients. In a recent project, payments to some sites were more than six months past due. Others paid for only two screen failures per patient randomized, and no payment was due until a patient was randomized.
Imagine the lack of motivation at sites which experienced three screen failures, all with significant out-of-pocket expenses. My question is not ‘why don’t they continue screening patients?’ My question is ‘why would they?’
To learn more about how Clinical SCORE can help you identify specific issues hindering patient recruitment and enrollment in your trials, please contact me.
Ross H. Weaver, PharmD, MBA